Surgery vs Casting for Idiopathic Toe Walking

(ITW Trial)

Recruiting at 7 trial locations

Overseen By Susan Sienko, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Shriners Hospitals for Children

Disqualifiers: Autism, Trauma, Neuromuscular, Neurogenic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares the effectiveness of two treatments for children who frequently walk on their toes without a known cause, a condition often called idiopathic toe walking. The treatments are serial casting, which involves applying a series of casts to gradually stretch muscles, and surgery. Researchers aim to determine which treatment improves movement and parent satisfaction more effectively. They also seek to explore any specific genes linked to this condition. Children with idiopathic toe walking who struggle to lift their toes upward, even with straight legs, might be suitable for this study. As an unphased trial, this study provides a unique opportunity for participants to contribute to understanding and improving treatments for idiopathic toe walking.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both serial casting and surgery are safe treatments for idiopathic toe walking (ITW).

For serial casting, studies have found it generally safe. In one study, 66% of children improved their walking patterns without major side effects, with most stopping toe walking after casting. Reports of serious issues from casting are not significant.

Surgery, such as lengthening the Achilles tendon, is also considered safe. Research indicates it effectively reduces toe walking in many patients. Specifically, one study found that older children with tight Achilles tendons responded well to surgery, experiencing no major complications.

Both treatments have a strong safety record, making them reliable options for treating ITW. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments for idiopathic toe walking because they offer unique approaches compared to standard options. Serial casting involves applying repeated casts weekly to gradually achieve the desired dorsiflexion range, providing a non-invasive method that allows for continuous adjustment over time. On the other hand, surgery directly targets the underlying issue by addressing the gastrocnemius muscle and/or the plantar fascia, potentially offering a more permanent solution. These options provide alternatives to traditional physical therapy or orthotic devices, and they may lead to improved outcomes by either gradually correcting the toe walking or by directly addressing its root cause.

What evidence suggests that this trial's treatments could be effective for idiopathic toe walking?

This trial will compare Serial Casting and Surgery for treating idiopathic toe walking. Research has shown that serial casting, one of the treatments in this trial, can effectively improve ankle movement in children who walk on their toes without a known cause. Studies have found that this method not only enhances ankle movement but also reduces toe walking. Conversely, surgery, another treatment option in this trial, greatly improves walking patterns and reduces pain. Specifically, surgery has significantly decreased toe walking. Both treatments offer major improvements, but the choice may depend on the child's specific needs and conditions. ^{1 3 6 7 8}

Who Is on the Research Team?

Jeremy Bauer, MD

Principal Investigator

Shriners Hospitals for Children-Portland

Are You a Good Fit for This Trial?

This trial is for children with idiopathic toe walking (ITW), a condition where they walk on their toes without any known cause. The study seeks participants who have not responded to other treatments and are eligible for either non-operative or operative interventions.

Inclusion Criteria

I am between 6 and 18 years old.

I have been diagnosed with persistent idiopathic toe walking.

My ankle movement is limited, with less than 5 degrees of upward flex.

Exclusion Criteria

Presence of any indicators of trauma, neuromuscular influence or neurogenic influence as identified by using the Toe Walking Tool

Diagnosis of Autism or autism spectrum disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either serial casting or surgery for idiopathic toe walking

6 months

Weekly visits for casting or surgical follow-up

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

2 visits (in-person) at 6 months and 1 year post intervention

Genetic Analysis

Whole genome sequencing is conducted to identify potential genetic determinants of idiopathic toe walking

Baseline

What Are the Treatments Tested in This Trial?

Interventions

• Serial Casting
• Surgery

Trial Overview The trial is testing two different approaches: serial casting, which involves applying casts to the legs to promote normal walking, and surgery aimed at correcting the toe-walking gait. It also aims to identify if specific genes are linked to ITW.

How Is the Trial Designed?

Group I: Serial Casting Active Control 1 Intervention

Repeated casts weekly until desired dorsiflexion range achieved

Group II: Surgery Active Control 1 Intervention

Surgical procedure to the gastrocnemius and/or plantar fascia

Serial Casting is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Serial Casting for:

• Idiopathic Toe Walking
• Cerebral Palsy
• Spina Bifida
• Muscle Spasticity

Approved in European Union as Serial Casting for:

• Idiopathic Toe Walking
• Cerebral Palsy
• Spina Bifida
• Muscle Spasticity

Approved in Canada as Serial Casting for:

• Idiopathic Toe Walking
• Cerebral Palsy
• Spina Bifida
• Muscle Spasticity

Who Is Running the Clinical Trial?

Shriners Hospitals for Children

Lead Sponsor

Trials

98

Recruited

23,900+

Published Research Related to This Trial

A study involving 126 infants with clubfoot found that treatment outcomes using the Ponseti method were equivalent whether performed by orthopaedic surgeons or physical therapists, with no significant differences in recurrence rates or need for additional surgery.

Although orthopaedic surgeons tended to use fewer casts on average, the difference was minimal and not clinically significant, indicating that both specialists can effectively manage clubfoot treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective, Randomized Ponseti Treatment for Clubfoot: Orthopaedic Surgeons Versus Physical Therapists. Chen, SN., Ragsdale, TD., Rhodes, LN., et al.[2023]

The Ponseti method for treating idiopathic clubfoot was found to be effective and reliable in a study of 57 children (90 feet) in Southern Israel, with a significant portion (61.1%) requiring an Achilles tenotomy, especially in cases with a higher severity score.

While parental compliance to foot orthosis had a weak protective effect against relapse, other factors such as casting technique, duration in cast, and socioeconomic status also play important roles in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Influence of Achilles Tenotomy and Compliance with Foot Abduction Orthosis on the Relapse Rate of Ponseti Treatment for Idiopathic Clubfoot: A Regional Study. Cohen, E., Katz, T., Rozen, U., et al.[2021]

Serial casting, followed by the use of ankle-foot orthoses, effectively improved gait in a child with autism spectrum disorder (ASD) who exhibited toe walking and equinus contractures, as evidenced by gait analysis.

The child maintained a consistent heel-toe gait pattern for two years after treatment, suggesting that this intervention can provide long-term benefits for similar cases in children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinematic Gait Changes Following Serial Casting and Bracing to Treat Toe Walking in a Child With Autism. Barkocy, M., Dexter, J., Petranovich, C.[2018]

Dynamic splinting combined with physical therapy was effective in treating a child with toe-walking due to right hemiparesis, leading to a 14-degree increase in passive dorsiflexion over four months.

The patient was able to walk with a 'flat foot' contact without the need for an Ankle Foot Orthosis, demonstrating that this approach can improve gait patterns and strength more effectively than traditional serial casting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic splinting home therapy for toe walking: a case report. Lundequam, P., Willis, FB.[2021]

A shortened program of the Ponseti technique for treating congenital clubfoot, involving serial casting twice a week, was effective, with 65% of patients showing improvement in less than three weeks, which is at least two weeks shorter than the traditional method.

Despite some complications, such as pressure ulcers and one case of hospital-acquired pneumonia, all patients achieved successful correction of their clubfoot, indicating that the shortened treatment program is safe and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of shortened program of Ponseti technique for congenital clubfoot. Sugandhavesa, N., Cheewawattanachai, C., Luevitoonvechkij, S., et al.[2018]

In a study of 47 patients with severe idiopathic clubfoot, 38.3% experienced difficulties during the Ponseti casting process, which were linked to higher initial Dimeglio scores, greater equinus deformity, and shorter foot length.

Patients who faced difficulties during casting had a significantly higher rate of needing further surgery (94.4%) due to residual or recurrent deformity compared to those without difficulties (62.1%), indicating that certain physical characteristics may predict treatment challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Difficulties During Ponseti Casting for the Treatment of Idiopathic Clubfoot. Ko, KR., Shim, JS., Kim, JH., et al.[2020]

In a study of 27 patients using the Ponseti technique for idiopathic congenital clubfoot, only 3% required extensive posteromedial release (PMR), compared to 94% in a matched control group, demonstrating the Ponseti method's high efficacy.

The Ponseti technique involved a shorter average casting duration of 2 months and included percutaneous Achilles tenotomy in 91% of cases, suggesting a less invasive approach that may lead to better long-term outcomes and reduced need for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ponseti versus traditional methods of casting for idiopathic clubfoot. Herzenberg, JE., Radler, C., Bor, N.[2022]

In a study of 136 children with idiopathic toe-walking, observation showed that only 6% achieved normal gait, while 45% improved, indicating that many children may not fully outgrow the condition without intervention.

Surgical treatment resulted in a higher percentage of children walking normally (22% patient-determined, 37% physician-determined) compared to observation or casting, suggesting that surgery may have a beneficial impact, although the criteria for surgery need further clarification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Idiopathic toe-walking: does treatment alter the natural history? Eastwood, DM., Menelaus, MB., Dickens, DR., et al.[2019]

In a study of 54 previously treated clubfeet, 9 cases developed complex iatrogenic deformities due to improper casting techniques, highlighting the importance of correct manipulation in treatment.

Using the modified Ponseti protocol, the long-term follow-up (averaging 7.2 years) showed that while treatment was effective, there was a 55% relapse rate in complex clubfeet, indicating the need for careful monitoring and possible additional interventions like tendon surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex iatrogenic clubfoot: is it a real entity? Dragoni, M., Gabrielli, A., Farsetti, P., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11307011/

Efficacy of serial casting protocols in idiopathic toe-walking In conclusion, this study validated that serial casting improves ROM at the ankle in ITW, regardless of serial casting regimen. Further, greater ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40167594/

A comparative randomized-controlled trial of serial casting ... Primary outcomes were ankle dorsiflexion range of motion (ROM) and the Toe Walking Severity Scale (TWSS). The secondary outcomes included pediatric outcomes ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0966636225004096

Short-Term Treatment Outcomes for Idiopathic Toe Walking Casting and surgery result in substantial and nearly equivalent improvements in gait in a homogeneous cohort of children with ITW and mild tendo-Achilles ...

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.3233/PRM-230041

Efficacy of serial casting protocols in idiopathic toe-walking This study suggests greater improvement in ROM in the one-week vs. two-week casting interval group.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06010485

The Effect of Serial Casting and Physical Therapy in ... The study's aim was to investigate the effects of serial casting and physical therapy on joint range of motion (ROM), toe walking severity, functional health ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6442509/

Serial ankle casts for patients with idiopathic toe walking The aim of the present study was to investigate the functional effects on gait parameters of serial ankle casts for patients with idiopathic toe walking (ITW)

7. researchgate.net researchgate.net/publication/6542779_Serial_casting_in_the_treatment_of_idiopathic_toe-walkers_and_review_of_the_literature

Serial casting in the treatment of idiopathic toe-walkers and ... Following casting, 66% of patients had improved gait on patient and clinician determined outcomes, with the majority of children ceasing to toe- ...

8. journals.lww.com journals.lww.com/jaaos/fulltext/2022/11150/idiopathic_toe_walking__an_update_on_natural.7.aspx

Idiopathic Toe Walking: An Update on Natural History,... ITWp is used to describe persistent walking in a toe-toe pattern and can include both children with and without a contracture at the ankle.